A Phase 2/3 interventional study of Ranibizumab and Mitomycin (MMC) in Glaucoma, sponsored by Wills Eye. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-22.
Sponsored by Wills Eye · Phase 2/3, Interventional, and Treatment
Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include late bleb leaks, hypotony and infection.
This is an open-label, single center trial with two arms for patients who underwent guarded filtration surgery to control glaucoma. The control will consist of patients randomly assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab 0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the surgery. No mitomycin C will be applied.
Post operative follow-up will consist of a minimum of 6 visits during a one year period.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 24 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Wills Eye is the lead sponsor of 74 studies on the registry; 3 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriorly to the limbus as an antifibrotic agent.
Drug: Ranibizumab
Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. This is the typical method used as an antifibrotic agent.
Drug: Mitomycin (MMC)
Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
Also known as: Lucentis
Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
Also known as: MMC C 0.4 mg/ml
Adverse Events
Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively.
Time frame: 12 months
Post-Operative Requirement for Glaucoma Medication
Mean number of glaucoma medications used by each participant over the course of one year post-operatively.
Time frame: 1 day, 2 wks, 1, 3, 6 and 12 months
| Milestone | Treatment 1 (Ranibizumab 0.5mg) | Treatment 2 (Mitomycin C 0.4 mg/ml) |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively.
| percentage of participants | Treatment 1 (Ranibizumab 0.5mg) | Treatment 2 (Mitomycin C 0.4 mg/ml) |
|---|---|---|
| Adverse Events | 100 | 16.67 |
Mean number of glaucoma medications used by each participant over the course of one year post-operatively.
| number of glaucoma medications used | A: Ranibizumab 0.5mg (0.05mL) Injection | B: Mitomycin C 0.4 mg/ml Sponge |
|---|---|---|
| 1 Day | 0.01 (0.0 to 0.20) | 0.0 (0.0 to 0.05) |
| 2 wks | 0.0 (0.0 to 0.11) | 0.01 (0.0 to 0.10) |
| 1 month | 0.13 (0.0 to 0.46) | 0.01 (0.0 to 0.10) |
| 3 months | 0.66 (0.22 to 1.33) | 0.08 (0.0 to 0.26) |
| 6 months | 0.34 (0.05 to 0.89) | 0.06 (0.0 to 0.24) |
| 12 months | 0.15 (0.0 to 0.57) | 0.06 (0.0 to 0.22) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment 1 (Ranibizumab 0.5mg) | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| Treatment 2 (Mitomycin C 0.4 mg/ml) | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Event | Treatment 1 (Ranibizumab 0.5mg) | Treatment 2 (Mitomycin C 0.4 mg/ml) |
|---|---|---|
| needling of the blebEye disorders | 5/12 | 1/12 |
| choroidal detachmentEye disorders | 3/12 | 1/12 |
| optic nerve swellingEye disorders | 2/12 | 0/12 |
| choroidal foldsEye disorders | 1/12 | 0/12 |
| macular/retinal foldsEye disorders | 1/12 | 0/12 |
| Age, Continuous(Years) | Treatment 1 (Ranibizumab 0.5mg) | Treatment 2 (Mitomycin C 0.4 mg/ml) | Total |
|---|---|---|---|
| Median | 67 (40 to 85) | 68.5 (42 to 90) | 67.75 (40 to 90) |
| Age, Categorical(Participants) | Treatment 1 (Ranibizumab 0.5mg) | Treatment 2 (Mitomycin C 0.4 mg/ml) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 4 | 5 |
| >=65 years | 11 | 8 | 19 |
| Sex: Female, Male(Participants) | Treatment 1 (Ranibizumab 0.5mg) | Treatment 2 (Mitomycin C 0.4 mg/ml) | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 6 | 6 | 12 |
| Region of Enrollment(participants) | Treatment 1 (Ranibizumab 0.5mg) | Treatment 2 (Mitomycin C 0.4 mg/ml) | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
Plan to share: No
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